OncoMed receives Orphan Drug Designation from the FDA for Demcizumab in pancreatic cancer
OncoMed Pharmaceuticals Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that the U.S. Food and Drug Administration (FDA) Department of Orphan Products Development has granted orphan drug designation to demcizumab (anti-DLL4, OMP-21M18) for the treatment of pancreatic cancer.
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REDWOOD CITY, Calif.—OncoMed Pharmaceuticals Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that the U.S. Food and Drug Administration (FDA) Department of Orphan Products Development has granted orphan drug designation to demcizumab (anti-DLL4, OMP-21M18) for the treatment of pancreatic cancer. OncoMed is currently conducting a Phase 1b clinical trial of demcizumab in combination with Abraxane® (nab-paclitaxel) and gemcitabine in first-line Stage IV pancreatic cancer patients.
"We are very pleased that the FDA designated demcizumab as an orphan drug for the treatment of pancreatic cancer which is a major unmet medical need,” said Paul J. Hastings, chairman and CEO of OncoMed. “Based on the encouraging safety and response data achieved to date for demcizumab in OncoMed's Phase 1a and 1b clinical studies, we anticipate advancing demcizumab into a randomized Phase 2 clinical study in combination with Abraxane and gemcitabine in first-line pancreatic cancer in 2014."
According to the American Cancer Society, there are approximately 46,000 new cases of pancreatic cancer each year in the United States. The majority of patients with pancreatic cancer are diagnosed after their cancer has spread locally and/or metastasized to distant organs. Rates of pancreatic cancer have been increasing over the past ten years
and it is now the fourth-leading cause of cancer-related deaths. The average life expectancy after the diagnosis of metastatic pancreatic cancer is less than one year.
The FDA's Orphan Drug program provides orphan status to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. This designation provides eligibility for a seven-year period of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design, and an exemption from FDA user fees.
Demcizumab is a humanized monoclonal antibody that inhibits Delta-Like Ligand 4 (DLL4) in the Notch signaling pathway. Two Phase 1b combination trials of demcizumab are ongoing. The first trial is in combination with standard-of-care gemcitabine and Abraxane in first-line advanced pancreatic cancer patients, and the second trial is in combination with standard-of-care carboplatin and pemetrexed (Alimta®) in patients with first-line advanced non-small cell lung cancer (NSCLC). In addition, a Phase 1b/2 trial of demcizumab and paclitaxel in patients with platinum-resistant ovarian cancer is ongoing at The University of Texas MD Anderson Cancer Center. Interim data from the demcizumab clinical study in pancreatic patients were presented in January 2014 at the Gastrointestinal Cancers Symposium held in San Francisco, CA. Data from the ongoing demcizumab NSCLC Phase 1b study were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA, in October 2013. Demcizumab is part of OncoMed's collaboration with Celgene Corporation. The company also has strategic alliances with Bayer Pharma AG and GlaxoSmithKline.
OncoMed’s pipeline is focused on the development of novel monoclonal antibodies that target cancer stem cells (CSCs), which are the subpopulation of cells in a tumor responsible for driving growth and metastasis of the tumor. CSCs, also known as tumor-initiating cells, exhibit certain properties which include the capacity to divide and give rise to new CSCs, as well as the capacity to differentiate or change into the other cells that form the bulk of the tumor. Common cancer drugs target bulk tumor cells but have limited impact on CSCs, thereby providing a path for recurrence of the tumor. OncoMed’s product candidates target CSCs by blocking self-renewal and driving differentiation of CSCs toward a non-tumorigenic state, and also impact bulk tumor cells. OncoMed believes that its product candidates are distinct from the current generations of chemotherapies and targeted therapies, and have the potential to significantly impact cancer treatment and the clinical outcome of patients with cancer.
"We are very pleased that the FDA designated demcizumab as an orphan drug for the treatment of pancreatic cancer which is a major unmet medical need,” said Paul J. Hastings, chairman and CEO of OncoMed. “Based on the encouraging safety and response data achieved to date for demcizumab in OncoMed's Phase 1a and 1b clinical studies, we anticipate advancing demcizumab into a randomized Phase 2 clinical study in combination with Abraxane and gemcitabine in first-line pancreatic cancer in 2014."
According to the American Cancer Society, there are approximately 46,000 new cases of pancreatic cancer each year in the United States. The majority of patients with pancreatic cancer are diagnosed after their cancer has spread locally and/or metastasized to distant organs. Rates of pancreatic cancer have been increasing over the past ten years
and it is now the fourth-leading cause of cancer-related deaths. The average life expectancy after the diagnosis of metastatic pancreatic cancer is less than one year.
The FDA's Orphan Drug program provides orphan status to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. This designation provides eligibility for a seven-year period of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design, and an exemption from FDA user fees.
Demcizumab is a humanized monoclonal antibody that inhibits Delta-Like Ligand 4 (DLL4) in the Notch signaling pathway. Two Phase 1b combination trials of demcizumab are ongoing. The first trial is in combination with standard-of-care gemcitabine and Abraxane in first-line advanced pancreatic cancer patients, and the second trial is in combination with standard-of-care carboplatin and pemetrexed (Alimta®) in patients with first-line advanced non-small cell lung cancer (NSCLC). In addition, a Phase 1b/2 trial of demcizumab and paclitaxel in patients with platinum-resistant ovarian cancer is ongoing at The University of Texas MD Anderson Cancer Center. Interim data from the demcizumab clinical study in pancreatic patients were presented in January 2014 at the Gastrointestinal Cancers Symposium held in San Francisco, CA. Data from the ongoing demcizumab NSCLC Phase 1b study were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA, in October 2013. Demcizumab is part of OncoMed's collaboration with Celgene Corporation. The company also has strategic alliances with Bayer Pharma AG and GlaxoSmithKline.
OncoMed’s pipeline is focused on the development of novel monoclonal antibodies that target cancer stem cells (CSCs), which are the subpopulation of cells in a tumor responsible for driving growth and metastasis of the tumor. CSCs, also known as tumor-initiating cells, exhibit certain properties which include the capacity to divide and give rise to new CSCs, as well as the capacity to differentiate or change into the other cells that form the bulk of the tumor. Common cancer drugs target bulk tumor cells but have limited impact on CSCs, thereby providing a path for recurrence of the tumor. OncoMed’s product candidates target CSCs by blocking self-renewal and driving differentiation of CSCs toward a non-tumorigenic state, and also impact bulk tumor cells. OncoMed believes that its product candidates are distinct from the current generations of chemotherapies and targeted therapies, and have the potential to significantly impact cancer treatment and the clinical outcome of patients with cancer.
Privately held OncoMed has five anti-cancer product candidates in clinical development, including demcizumab (anti-DLL4, OMP-21M18), anti-Notch 2/3 (OMP-59R5), anti-Notch1 (OMP-52M51), vantictumab (anti-Fzd7, OMP-18R5), and Fzd8-Fc (OMP-54F28), which target key cancer stem cell signaling pathways including Notch and Wnt. OncoMed has two other antibodies in preclinical development, anti-DLL4/anti-VEGF bispecific (OMP-305B83) and anti-RSPO3, with Investigational New Drug filings planned for late 2014 or early 2015. OncoMed is also pursuing discovery of additional novel anti-CSC product candidates.
